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Risk of Fatigue in Adolescent and Young Adult Hodgkin Lymphoma Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vanderbilt University Medical Center ( Vanderbilt University )
ClinicalTrials.gov Identifier:
NCT01228461
First received: October 22, 2010
Last updated: March 30, 2017
Last verified: March 2017
  Purpose

Fatigue is one of the most prevalent symptoms endorsed by cancer survivors, particularly those treated for breast cancer or Hodgkin lymphoma. Despite the tremendous implications such work has for effective interventions, little is known about the underlying pathophysiology of fatigue, association with medical co-morbidities and factors that may help predict those to be at highest risk.

The proposed research will utilize Vanderbilt-Ingram Cancer Center REACH for Survivorship Program together with the investigators Hematologic Malignancies Program. In adolescent and young adults (AYA), ages 18 - 39 the investigators will address the following:

Primary Aims Aim 1: Assess the prevalence and severity of fatigue and its impact on functional outcomes Aim 2: Determine host, disease and treatment-related risk factors for fatigue

Secondary Aims Aim 1: Evaluate the association between levels of proinflammatory cytokine activity and fatigue Aim 2: Evaluate the association between fatigue and self reported fatigue in AYA Hodgkin lymphoma (HL) survivors.

Hypotheses:

  1. Fatigue is more prevalent and severe among AYA HL patients and survivors, compared to general population and will be associated with impaired functional outcome.
  2. Risk factors for fatigue include higher disease stage, B symptoms and elevated erythrocyte sedimentation rate at diagnosis, dose density of chemotherapy and higher doses and more expanded fields of radiotherapy.
  3. Risk of fatigue is associated with long-term cardiopulmonary and endocrine complications.
  4. Levels of specified proinflammatory cytokines are associated with increased fatigue.

Condition
Fatigue
Hodgkin Lymphoma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective

Resource links provided by NLM:


Further study details as provided by Vanderbilt University Medical Center:

Primary Outcome Measures:
  • Prevalence and severity of fatigue and its impact on functional outcomes [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • Evaluate the association between levels of proinflammatory cytokine activity and fatigue [ Time Frame: 1 year ]

Biospecimen Retention:   Samples Without DNA
Serum samples for IL-1ra and CRP

Enrollment: 10
Study Start Date: February 2010
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
AYA with Fatigue and Hodgkin Lymphoma

  Eligibility

Ages Eligible for Study:   15 Years to 39 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adolescents and young adult survivors of Hodgkin Lymphoma
Criteria

Inclusion Criteria:

  • Currently 18 years of age or older
  • Alive without evidence of recurrent disease
  • Must be off therapy (not on active treatment for HL or other malignancies)
  • Must not be on any form of chemotherapy (oral or intravenous [IV])
  • Provide informed consent
  • Can read and understand English
  • Treated with risk-adapted therapy which may include radiotherapy doses < 30 Gy

Exclusion Criteria:

  • Evidence of a subsequent malignancy following lymphoma treatment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01228461

Locations
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
  More Information

Responsible Party: Vanderbilt University
ClinicalTrials.gov Identifier: NCT01228461     History of Changes
Other Study ID Numbers: 091550
Study First Received: October 22, 2010
Last Updated: March 30, 2017

Keywords provided by Vanderbilt University Medical Center:
Hodgkin Lymphoma Survivors
Adolescent and Young Adults

Additional relevant MeSH terms:
Lymphoma
Hodgkin Disease
Fatigue
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on April 28, 2017